AstraZeneca Receives FDA Approval for Imfinzi in Biliary Tract Cancer

AstraZeneca today announced that the FDA has approved Imfinzi (durvalumab) in combination with gemcitabine and cisplatin for the treatment of adults with locally advanced or metastatic biliary tract cancer (BTC). In the Phase 3 TOPAZ-1 trial, Imfinzi plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone. The median OS was 12.8 months for Imfinzi plus chemotherapy versus 11.5 months for chemotherapy alone. This approval provides patients with BTC a new first-line treatment option combining immunotherapy with standard chemotherapy.